Pivotal trial of Moderna's H5N1 bird flu jab gets underway

 The first volunteers in a large-scale trial of Moderna's mRNA-based vaccine against bird flu – long considered to be a pandemic threat – have received shots in the UK and US.

The mRNA-1018 shot targets a new strain of the H5N1 strain of the influenza virus that has been decimating bird populations around the world over the last few years, and has also caused problems with livestock and killed hundreds of people around the world.

While the threat to humans is still considered to be low at the moment, with most cases resulting from close contact with infected birds and poultry, there is a risk that a mutation in the virus could make it more easily transmissible between species and lead to a serious outbreak.

Experience with the COVID-19 pandemic has shown that mRNA vaccines – which can be produced more quickly at scale than conventional shots – are a key technology that can underpin a response to an emerging pandemic threat.

The phase 3 trial of mRNA-1018 will evaluate the vaccine's safety and immunogenicity in around 4,000 healthy adults aged 18 years and older in the UK and US, with volunteers now being sought from poultry industry workers and the over-65s, who are most at risk.

"The first-of-its-kind pivotal trial of an mRNA-based pandemic influenza vaccine underscores the potential of this technology to reshape how we confront emerging pathogens," said Dr Richard Hatchett, chief executive of the Norway-headquartered Coalition for Epidemic Preparedness Innovations (CEPI), which coordinates projects between public, private, philanthropic, and civil organisations.

"If successful, these efforts could transform our ability to respond swiftly and equitably to one of the world's most enduring threats," he added.

Earlier this year, UK trials also started of various vaccines designed to protect livestock from avian influenza, focusing initially on turkeys.

Around three-quarters of the subjects in the mRNA-1018 trial will be recruited in the UK, reflecting Moderna's close relationship with the country, where it opened a flagship pandemic vaccine facility last year. Arguably at least, that split also reflects the prevailing climate of vaccine scepticism in the US, particularly for mRNA shots, which have had their safety and efficacy questioned and federal funding cut under HHS Secretary Robert F Kennedy Jr.

The primary endpoints will be safety and serological measures of efficacy, including the formation of antibodies against the virus. If successful, the results will be combined with data from trials of Moderna's recently filed seasonal influenza vaccine, mRNA-1010, in regulatory filings, said the company.

If mRNA-1018 gets approved for marketing, Moderna has pledged to provide 20% of its manufacturing capacity to low- and middle-income countries at affordable pricing, as part of an agreement with CEPI, which stepped in to fund the project after US federal funding was withdrawn.

"Most people do not have any pre-existing immunity to the H5N1 viruses [and] as we saw during the COVID pandemic, when people lack immunity, viruses spread faster and cause more disease," commented Prof John Tregoning, a vaccine immunology expert at Imperial College London.

There is a need to prepare against a species jump to humans, and "vaccines are a key part of this preparation," he added.

https://pharmaphorum.com/news/pivotal-trial-modernas-h5n1-bird-flu-jab-gets-underway